Tildrakizumab Clears Skin in Most Indian Psoriasis Patients in Phase III Trial

Indian patients with moderate-to-severe plaque psoriasis achieved striking skin clearance after just three doses of the interleukin-23 inhibitor tildrakizumab, according to a phase III bridging study published in Dermatology and Therapy. By week 28, 93.9 percent of the 114 patients who received at least one dose had reached PASI 75, meaning their Psoriasis Area and Severity Index scores had fallen by at least 75 percent from baseline, and 78.1 percent had reached PASI 90, a reduction of at least 90 percent.

That primary endpoint was met by 62.3 percent of patients in the modified intention-to-treat population at week 12, with a 95 percent confidence interval of 52.7 to 71.2 percent. Responses continued to deepen with continued dosing: 83.3 percent achieved PASI 75 by week 16 and 93.9 percent by week 28. PASI 90 responses followed the same trajectory, rising from 26.3 percent at week 12 to 50.0 percent at week 16 and 78.1 percent at week 28. Consistent results appeared in the intention-to-treat and per-protocol populations, which the authors reported as supportive analyses given the single-arm design.

Physician-assessed outcomes mirrored the objective measures. The proportion of patients rated as clear or minimal on the Physician’s Global Assessment, with at least a two-grade improvement from baseline, climbed from 63.2 percent at week 12 to 85.1 percent at week 16 and 91.2 percent at week 28. Deep clearance thresholds told a similar story: at week 28, 91.2 percent of patients had absolute PASI scores below 5, 86.8 percent below 3 and 61.4 percent below 1. Mean absolute PASI scores fell from a baseline of 21.1 by 16.4 points at week 12, 18.4 points at week 16 and 19.9 points at week 28, corresponding to percentage reductions of 76.7, 86.3 and 93.5 percent respectively, all statistically significant at p less than 0.0001.

Quality of life improved in parallel. The mean Dermatology Life Quality Index score dropped from 14.4 at baseline to 1.1 at week 28, a mean change of minus 13.2 points with a p value below 0.0001 at every timepoint measured. The authors note that the open-label design may introduce assessment bias for subjective outcomes such as the DLQI and the physician global assessment, a limitation they acknowledge explicitly alongside the absence of a comparator arm.

The safety profile was favourable over the 28-week treatment period. Among 114 patients in the safety population, 30 patients, or 26.3 percent, experienced 57 treatment-emergent adverse events, the large majority of them mild. The most common were pyrexia in 10.5 percent of patients, nasopharyngitis in 7.0 percent, pruritus in 4.4 percent and headache in 4.4 percent. One serious adverse event occurred, an acute myocardial infarction judged unrelated to the study drug, and there were no drug-related serious events, no discontinuations due to adverse events, no dose reductions and no deaths. All treatment-emergent events resolved without sequelae.

Immunogenicity was low. By week 28, 7.1 percent of the 113 patients tested had developed anti-drug antibodies, and four patients, 3.54 percent, also tested positive for neutralizing antibodies capable of blocking tildrakizumab’s binding to its target. Seven of the eight antibody-positive patients were treatment-emergent, having been antibody-negative at baseline. The authors caution that with so few antibody-positive patients, no formal inference can be drawn about any relationship between antibody status and clinical response; these findings are descriptive only. The observed rate falls within the 6.5 to 8.2 percent range reported in global phase III data over longer follow-up.

Tildrakizumab is a humanized IgG1 monoclonal antibody that selectively targets the p19 subunit of interleukin-23, a cytokine described as a master regulator of the immune-inflammatory cascade in psoriasis. By blocking interleukin-23 without affecting interleukin-12, the drug is designed to suppress pathogenic Th17 cell activation while theoretically preserving interleukin-12-mediated host defence. The drug was approved in India by the CDSCO in July 2025 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and the pivotal reSURFACE 1 and reSURFACE 2 trials had already demonstrated its efficacy internationally. The week 12 PASI 75 response of 62.3 percent in this Indian cohort closely matched the 63.8 percent and 61 percent responses seen in those two landmark trials, supporting the extrapolation of international data to the Indian population.

The dosing schedule carries practical weight in the Indian context. Tildrakizumab’s 12-week maintenance interval means six injections in the first year and four annually thereafter, compared with as many as 26 injections per year for some interleukin-17 inhibitors. The authors argue this reduced burden may help address adherence challenges common in chronic psoriasis management, particularly in resource-constrained settings, though they stress that comparative adherence was not directly evaluated in this study. Global pharmacoeconomic analyses cited by the authors position tildrakizumab among the more cost-effective first-line biologic options, a relevant consideration in a country where cost is the predominant barrier to biologic therapy.

The investigators are careful to frame the findings within the study’s limits. The single-arm design prevents any direct comparison with other biologics or conventional systemic agents, the 28-week duration cannot capture long-term durability or delayed adverse events, and the modest sample size limits detection of uncommon events. The cohort was 80.9 percent male, which may restrict generalizability to female patients, and no patients with concomitant psoriatic arthritis were enrolled, so joint outcomes could not be assessed. Because analyses used observed data without imputation, response rates at later visits may be influenced by participants with missing assessments. The authors conclude that longer-term comparative studies with larger, more diverse populations are needed to confirm the durability and relative effectiveness of tildrakizumab in Indian patients, while noting that these short-term results provide the first prospective evidence for an interleukin-23 inhibitor in this population.

Subject of Research: A phase III bridging trial of tildrakizumab in Indian patients with moderate-to-severe plaque psoriasis

Article Title: A Phase III, Open-Label, Single-Arm, Multicentric Study of Tildrakizumab in Indian Patients with Moderate-to-Severe Plaque Psoriasis

Article References: Kumar, S., Kumar, S., Krishna, V., Shivhare, D. P., Prasad, P. G., Kumar, H., Mamidwar, S., Pande, S., Dhawan, A., Patro, N., Patel, D., Shekar, C., Parasramani, S., Dogra, S., Sonawane, D., Patil, D., Shaikh, A., Pandit, S., Ghadge, P., & Mehta, S. (2026). A Phase III, Open-Label, Single-Arm, Multicentric Study of Tildrakizumab in Indian Patients with Moderate-to-Severe Plaque Psoriasis. Dermatology and Therapy. https://doi.org/10.1007/s13555-026-01957-x

Image Credits: AI Generated

DOI: 10.1007/s13555-026-01957-x

Keywords: tildrakizumab, psoriasis, interleukin-23, phase III trial, India, PASI 75, biologics, immunogenicity, drug safety, dermatology, quality of life, CDSCO